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FDA Approval

Tiagabine Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Novadoz Pharmaceuticals LLC

DUNS: 081109687

Effective Date

March 1, 2021

Labeling Type

Human Prescription Drug Label

Active Ingredients

Tiagabine(2 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

MSN LABORATORIES PRIVATE LIMITED

Labeler

Novadoz Pharmaceuticals LLC

DUNS Number

650786952

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tiagabine Hydrochloride

Product Details

NDC Product Code

72205-084

Application Number

ANDA214816

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 1, 2021

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671PClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 2 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

72205-086

Application Number

ANDA214816

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 1, 2021

Ingredients

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 12 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

72205-085

Application Number

ANDA214816

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 1, 2021

Ingredients

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 4 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Tiagabine Hydrochloride

Product Details

NDC Product Code

72205-087

Application Number

ANDA214816

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 1, 2021

Ingredients

TiagabineActive

Code: DQH6T6D8OYClass: ACTIBQuantity: 16 mg in 1 1

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

BUTYLATED HYDROXYANISOLEInactive

Code: REK4960K2UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671PClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

HYDROGENATED COTTONSEED OILInactive

Code: Z82Y2C65EAClass: IACT

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